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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K924051
Device Name KIT PAK I.V. START KIT
Applicant
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Applicant Contact THOMAS J SANDERS
Correspondent
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Correspondent Contact THOMAS J SANDERS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/12/1992
Decision Date 06/22/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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